During surgery or in the emergency room, it is frequently necessary to infuse blood or volume expanding fluids rapidly into a patient, particularly when massive blood losses have occurred. Patients having inadequate blood volume can suffer serious consequences.
There are many situations where large amounts of blood can be lost in a very short period of time, for example, in cases of serious automobile accidents, gun shot wounds in critical areas of the body, and a variety of plural surgeries including cancer surgery and heart and liver transplants.
In the past, the replacement of large amounts of blood loss has been a major problem to the surgical teams attending a suffering patient. A common method of rapid infusion includes the use of a plurality of infusion sites simultaneously. Infusion bags or bags of stored banked blood are interconnected by intravenous tubing. Frequently, a plurality of medical personnel are required to oversee the various infusion sites and to personally ensure the flow of blood from the blood bags.
Anesthesiologists and/or other ancillary staff are regularly involved with cardiopulmonary resuscitation, trauma and organ transplantation procedures, and with maintenance of patient hemodynamics during any operative or emergency procedure. During such procedures, patient blood loss cannot, practically speaking, always be contained by the operating surgeon and such blood must be replaced by the anesthesiologists standing in attendance. It is not uncommon for multiple anesthesiologists or technicians to stand in attendance during lengthy operations attempting to infuse massive quantities of blood through five or six venous catheters.
Clinical records obtained from actual operations involving trauma and liver transplantations reveal blood losses estimated to be in excess of two hundred and fifty liters, a volume approximately fifty times a normal adult's total blood volume. Although it is not uncommon for an anesthesiologist or trauma surgeon to encounter massive exsanguination (ten liters and more) in a major trauma and transplantation center, it is, however, unusual to successfully resuscitate a patient with such massive blood volume loss with traditional methods.
Stephens, Jr., et al., U.S. Pat. No. 5,061,241, disclose a rapid infusion device capable of high volume pumping composed of two units. A permanent unit comprising a base portion which houses an AC/DC motor, a roller pump, and other associated gauges and switches. A disposable unit includes a filter reservoir, heat exchange component, and associated tubing leading to the roller pump. The roller pump increases the volume of fluid being pumped by increasing the rpm of the pumping unit and includes a pressure control valve.
Sassano, U.S. Pat. No. 4,747,826, discloses an infusion apparatus consisting of supply sources, reservoirs, and associated tubes and valves leading to an infusion pump which can either be a roller head occlusive or centrifugal pump.
The rapid infusion of IV fluids has proven to save lives in patients suffering from blood loss. All rapid infusion devices presently available are large, heavy, prohibitively expensive, and extremely costly to operate because of special, extremely expensive components that have to be discarded after each use. All of these devices are large, cumbersome, difficult to use, require specialized training, require long set up time, use specialized tubing, do not have their own power supply and are not suitable to ambulance or field use. The prior art rapid-infusion devices cannot be used with typical peripheral IV cannulas but require large-bore central-line or venous cut-down catheters which can be inserted only by physicians. Although rapid infusion, or hyperinfusion, is a proven life saver, this technology is not commonly available to the public in most hospitals because of the aforementioned reasons.